Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements, 67060-67065 [2021-25615]
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EXEMPTIONS PROMULGATED FOR THE SYSTEM:
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HISTORY:
84 FR 16493–16510 (April 19, 2019)
80 FR 9460–9465 (February 23, 2015)
74 FR 17863–17866 (April 17, 2009)
73 FR 33591–33634 (June 12, 2008).
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2021–25637 Filed 11–23–21; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1721]
See § 4.13 of the FTC’s Rules of
Practice, 16 CFR 4.13. For additional
guidance, see also Appendix II (How To
Make A Privacy Act Request), available
on the FTC’s website at https://
www.ftc.gov/about-ftc/foia/foia-readingrooms/privacy-act-systems and at 73 FR
33592, 33634 (June 12, 2008). Current
FTC employees may also access their
records directly by utilizing OPM’s
approved electronic Official Personnel
Folder system, using their assigned user
ID and password.
Former FTC employees subsequently
employed by another Federal agency
should contact the personnel office for
their current Federal employer. Former
employees who have left Federal service
and want access to their official
personnel records in storage should
contact the National Personnel Records
Center, 1411 Boulder Boulevard,
Valmeyer, IL 62295.
VerDate Sep<11>2014
See § 4.13 of the FTC’s Rules of
Practice, 16 CFR 4.13. For additional
guidance, see also Appendix II (How To
Make A Privacy Act Request), available
on the FTC’s website at https://
www.ftc.gov/about-ftc/foia/foia-readingrooms/privacy-act-systems and at 73 FR
33592, 33634 (June 12, 2008). Current
FTC employees may also access their
records directly by utilizing OPM’s
approved electronic Official Personnel
Folder system, using their assigned user
ID and password.
Former FTC employees subsequently
employed by another Federal agency
should contact the personnel office for
their current Federal employer. Former
employees who have left Federal service
and want access to their official
personnel records in storage should
contact the National Personnel Records
Center, 1411 Boulder Boulevard,
Valmeyer, IL 62295.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
New Drug Application Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
SUMMARY:
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solicits comments on information
collection associated with
investigational new drug application
requirements.
Submit either electronic or
written comments on the collection of
information by January 24, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 24,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 24, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1721 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Investigational New Drug
Applications.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
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Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Investigational New Drug
Applications—21 CFR Part 312
OMB Control Number 0910–0014—
Revision
This information collection supports
implementation of provisions of section
505 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355) and of the licensing provisions of
the Public Health Service Act (42 U.S.C.
201 et seq.) that govern investigational
new drugs and investigational new drug
applications (INDs). Implementing
regulations are found in part 312 (21
CFR part 312), and provide for the
issuance of guidance documents (see
§ 312.145 (21 CFR 312.145)) to assist
persons in complying with the
applicable requirements. The
information collection applies to all
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clinical investigations subject to section
505 of the FD&C Act and include the
following types of INDs:
• An Investigator IND is submitted by
a physician who both initiates and
investigates, and under whose
immediate direction the investigational
drug is administered or dispensed. A
physician might submit a research IND
to propose studying an unapproved
drug or an approved product for a new
indication or in a new patient
population.
• Emergency Use IND allows FDA to
authorize use of an experimental drug in
an emergency situation that does not
allow time for submission of an IND in
accordance with § 312.23 or § 312.20 (21
CFR 312.23 or 312.20). It is also used for
patients who do not meet the criteria of
an existing study protocol or if an
approved study protocol does not exist.
• Treatment IND is submitted for
experimental drugs showing promise in
clinical testing for serious or
immediately life-threatening conditions
while the final clinical work is
conducted and FDA’s review takes
place.
There are two IND categories:
Commercial and research (noncommercial).
General IND requirements include
submitting an initial application as well
as amendments to that application;
submitting reports on significant
revisions of clinical investigation plans;
submitting information to the clinical
trials data bank (https://
clinicaltrials.gov) established by the
National Institutes of Health/National
Library of Medicine, including
expanded information on certain
clinical trials and information on the
results of these clinical trials; and
reporting information on a drug’s safety
or effectiveness. In addition, sponsors
are required to provide to FDA an
annual summary of the previous year’s
clinical experience. The regulations also
include recordkeeping requirements
regarding the disposition of drugs,
records regarding individual case
histories, and certain other
documentation verifying clinical
investigators’ fulfillment of
responsibilities.
Form FDA 1571 entitled
‘‘Investigational New Drug Application
(IND)’’ and Form FDA 1572 entitled
‘‘Statement of Investigator,’’ were
developed to assist respondents with
the information collection and provide
for uniform reporting of required data
elements. The information is required to
be submitted electronically. Individuals
who are interested in receiving printed
forms may send an email request to the
FDA Forms Manager at
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formsmanager@OC.FDA.GOV. Fees may
apply. Sponsors (including sponsorinvestigators) interested in filing or
updating a research IND may use a new
web-based interface developed for use
by mobile device or desktop to help in
completing Form FDA 1571. The webbased interface also allows respondents
to electronically submit completed
Form FDA 1571 and associated files. For
more information regarding Forms FDA
1571 and 1572 visit https://
www.fda.gov/news-events/expandedaccess/how-complete-form-fda-1571and-form-fda-1572.
Human drug, biological product, and
device product submissions must be
accompanied by Form FDA 3674,
‘‘Certification To Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ The
guidance document ‘‘Form FDA 3674—
Certifications To Accompany Drug,
Biological Product, and Device
Application’’ (November 2017) is
available from our website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/formfda-3674-certifications-accompanydrug-biological-product-and-deviceapplicationssubmissions and provides
instruction on completing and
submitting this information to FDA. As
communicated in the instructions, the
certification must accompany the
application or submission and be
included at the time of submission to
FDA.
Regulations in part 312, subpart B,
specify content and format requirements
for applications, amendments, annual
reporting, and withdrawals, including
content and format requirements for
protocol and information amendments.
The regulations also explain phases of
an investigation and set forth principles
of IND submissions.
Regulations in part 312, subpart C,
describe administrative actions
pertaining to respondents’ requests for
and responses to clinical holds,
terminations, and inactive IND status
determinations, as well as various types
of meetings (for example, End-of-Phase
2 and Pre-new drug application (NDA)
meetings).
Regulations in part 312, subpart D, set
forth sponsor and investigator
responsibilities, including general
responsibilities; transfer of obligations
to a contract research organization;
recordkeeping and record retention
controls; reporting responsibilities; and
responsibility for disposition of unused
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supply of investigational drug. The
regulations also provide for investigator
controls including review of ongoing
investigations; compliance with
requirements regarding the protection of
human subjects and institutional review
board assurance; and disqualification of
clinical investigators.
Regulations in part 312, subpart E,
sets forth requirements applicable to
drugs intended to treat life-threatening
and severely debilitating illnesses. The
regulations establish procedures to
reflect that physicians and patients
accept greater risk or side effects from
products that treat life-threatening and
severely debilitating illnesses than they
would accept from products that treat
less serious illnesses. The procedures
also reflect the recognition that the
benefits of the drug need to be evaluated
in light of the severity of the disease
being treated.
Regulations in part 312, subpart F,
include provisions pertaining to import
and export requirements; foreign
clinical studies not conducted under an
IND; the disclosure of data and
information in an IND; and the issuance
of guidance documents. We are revising
the information collection to account for
burden that may be associated with
recommendations found in Agency
guidance documents.
• The guidance document entitled
‘‘Oversight of Clinical Investigations’’
(August 2013) communicates risk-based
monitoring strategies and recommends
plans for investigational studies of
medical products, including human
drug and biological products, medical
devices, and combinations thereof. The
guidance document is intended to
enhance human subject protection and
the quality of clinical trial data by
focusing sponsor oversight on the most
important aspects of study conduct and
reporting. The guidance also
communicates that sponsors can use a
variety of approaches to fulfill
responsibilities for monitoring clinical
investigator conduct and performance in
IND studies, and provides a description
of strategies for monitoring activities to
reflect a modern, risk-based approach.
• The guidance document entitled
‘‘Pharmacogenomic Data Submissions’’
(March 2005) provides
recommendations intended to assist
sponsors submitting or holding INDs,
NDAs, or biologics license applications
(BLAs) with submission requirements
for relevant data regarding drug safety
and effectiveness (including §§ 312.22,
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312.23, 312.31, 312.33, 314.50, 314.81,
601.2, and 601.12 (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81,
601.2 and 601.12)). Because the
regulations were developed before the
advent of widespread animal or human
genetic or gene expression testing, the
regulations do not specifically address
when such data must be submitted. The
guidance document includes content
and format recommendations regarding
pharmacogenomic data submissions.
Although we have not received any
pharmacogenomic submissions since
2013, we assume an average of 50 hours
for preparing and providing information
to FDA as recommended in the
guidance and estimate one submission
annually.
• The guidance document entitled
‘‘Adaptive Designs for Clinical Trials of
Drugs and Biologics’’ (December 2019)
was developed to assist sponsors and
applicants submitting INDs, NDAs,
BLAs, or supplemental applications on
the appropriate use of adaptive designs
for clinical trials to provide evidence of
the effectiveness and safety of a drug or
biologic. The guidance document
describes important principles for
designing, conducting, and reporting the
results from an adaptive clinical trial,
and advises sponsors on the types of
information to submit to facilitate FDA
evaluation of clinical trials with
adaptive designs, including Bayesian
adaptive and complex trials that rely on
computer simulations for their design.
The referenced guidance documents
are available for download from our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-document and were issued
consistent with § 312.145 to help
respondents comply with requirements
in part 312. In publishing the respective
notices of availability for each guidance
document, we included an analysis
under the PRA and invited public
comment on the associated information
collection recommendations. In
addition, all Agency guidance
documents are issued in accordance
with our Good Guidance Practice
regulations in 21 CFR 10.115, which
provide for public comment at any time.
Regulations in part 312, subpart G,
provide for drugs for investigational use
in laboratory research animals or in
vitro tests.
We estimate the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
Average
burden per
response
Total annual
responses
Total hours
Subpart A—General Provisions: §§ 312.1 through 312.10
§ 312.2(e); requests for FDA advice on the applicability of part 312 to a
planned clinical investigation .............................................................................
§ 312.8; requests to charge for an investigational drug .......................................
§ 312.10; waiver requests .....................................................................................
Subtotal Subpart A Center for Biologics Evaluation and Research (CBER)
454
14
5
1.528
1.64
1
694
23
5
24
48
24
16,656
1,104
120
I ........................
........................
722
........................
17,880
Subpart B—Investigational New Drug Application (IND): §§ 312.20 through 312.38 (Including Forms FDA 1571, 1572, and 3674)
§ 312.23(a) through (f); IND content and format ..................................................
§ 312.30(a) through (e); Protocol amendments ....................................................
§ 312.31(b); information amendments ..................................................................
§ 312.32(c) and (d); IND Safety reports ................................................................
§ 312.33(a) through (f); IND Annual reports .........................................................
§ 312.38(b) and (c); notifications of withdrawal of an IND ...................................
2,075
1,781
169
224
971
712
3.382
4.6692
2.48
10.59
2.2739
3.057
7,018
8,316
419
2,372
2,208
2,177
300
284
100
32
360
28
2,105,400
2,361,744
41,900
75,904
794,880
60,956
Subtotal Subpart B CBER .............................................................................
........................
........................
22,510
........................
5,440,784
Subpart C—Administrative Actions: §§ 312.40 through 312.48
§ 312.42; clinical holds and requests for modification ..........................................
§ 312.44(c) and (d); sponsor responses to FDA when IND is terminated ...........
§ 312.45(a) and (b); sponsor requests for or responses to an inactive status
determination of an IND by FDA .......................................................................
§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’
meetings ............................................................................................................
Subtotal Subpart C CBER .............................................................................
154
86
1.65
1.22
254
105
284
16
72,136
1,680
48
1.48
71
12
852
157
1.80
283
160
45,280
........................
........................
713
........................
119,948
Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 through 312.70
§ 312.53(c); investigator reports submitted to the sponsor, including Form
FDA–1572, curriculum vitae, clinical protocol, and financial disclosure ...........
§ 312.54(a); sponsor submissions to FDA concerning investigations involving
an exception from informed consent under § 50.24 ..........................................
§ 312.54(b); sponsor notifications to FDA and others concerning an institutional
review board determination that it cannot approve research because it does
not meet the criteria in the exception from informed consent in § 50.24(a) .....
§ 312.55(a); number of investigator brochures submitted by the sponsor to
each investigator ...............................................................................................
§ 312.55(b); number of sponsor reports to investigators on new observations,
especially adverse reactions and safe use .......................................................
§ 312.56(b), (c), and (d); review of ongoing investigations and associated notifications; sponsor notifications ............................................................................
§ 312.58; inspection of records and reports by FDA ............................................
§ 312.64; number of investigator reports to the sponsor, including progress reports, safety reports, final reports, and financial disclosure reports .................
§ 312.70; disqualification of a clinical investigator by FDA ...................................
Subtotal Subpart D CBER .............................................................................
1,068
5.23
5,586
80
446,880
4
4.25
17
48
816
1
1
1
48
48
473
2.224
1,052
48
50,496
243
4.95
1,203
48
57,744
915
7
2.948
1
2,698
7
80
8
215,840
56
2,728
5
3.816
1
10,411
5
24
40
249,864
200
........................
........................
20,980
........................
1,021,944
Subpart F—Miscellaneous: §§ 312.110 through 312.145
§ 312.110(b)(4) and (b)(5); number of written certifications and written statements submitted to FDA relating to the export of an investigational drug .......
§ 312.120(b); number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND ..........
§ 312.120(c); number of waiver requests submitted to FDA related to the use of
foreign clinical studies not conducted under an IND ........................................
§ 312.130; number of requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 ......
18
1
18
75
1,350
280
9.82
2,750
32
88,000
7
2.29
16
24
384
350
1.342
470
8
3,760
Subtotal Subpart F CBER ..............................................................................
........................
........................
3,254
........................
93,494
Total ........................................................................................................
........................
........................
48,179
........................
6,694,050
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
recordkeepers
21 CFR section; information collection activity
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Subpart D—Responsibilities of Sponsors and Investigators: §§ 312.50 Through 312.70
§ 312.52(a); sponsor records for the transfer of obligations to a contract research organization.
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2 ..................................
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1—Continued
Number of
recordkeepers
21 CFR section; information collection activity
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
§ 312.57; sponsor recordkeeping showing the receipt, shipment, or
other disposition of the investigational drug, and any financial interest.
§ 312.62(a); investigator recordkeeping of the disposition of drugs ......
§ 312.62(b); investigator recordkeeping of case histories of individuals
335
2.70
904
100 ..............................
90,400
453
453
1
1
453
453
40 ................................
40 ................................
18,120
18,120
Subtotal Subpart D CBER ..............................................................
..........................
........................
2,022
.....................................
127,064
Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.160(c) shipper records of alternative disposition of unused
drugs.
111
1.40
155
0.5 (30 minutes) .........
78
111
1.40
155
0.5 (30 minutes) .........
78
Subtotal Subpart G CBER ..............................................................
..........................
........................
310
.....................................
156
Total .........................................................................................
..........................
........................
2,332
.....................................
127,220
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
Average
burden per
response
Total annual
responses
Total hours
Subpart A—General Provisions
§ 312.2(e); requests for FDA advice on the applicability of part 312 to a
planned clinical investigation ...........................................................................
§ 312.8; requests to charge for an investigational drug .....................................
§ 312.10; requests to waive a requirement in part 312 ......................................
419
25
68
1
1.28
1.5
419
32
102
24
48
24
10,056
1,536
2,448
Subtotal Subpart A Center for Drug Evaluation and Research (CDER) .....
..........................
........................
553
........................
14,040
Subpart B—Investigational New Drug Application (IND)
§ 312.23(a) through (f); IND content and format (including Forms FDA 1571
and 3674) ........................................................................................................
§ 312.30(a) through (e); protocol amendments ..................................................
§ 312.31(b); Information amendments ................................................................
§ 312.32(c) and (d); IND safety reports ..............................................................
§ 312.33(a) through (f); IND annual reports ........................................................
§ 312.38(b) and (c); notifications of withdrawal of an IND .................................
4,886
11,847
8,094
892
3,777
1,549
1.4662
3.2367
3.30899
15.848
2.9097
1.834
7,164
38,346
26,783
14,137
10,990
2,841
300
284.25
100
32
360
28
2,149,200
10,899,850
2,678,300
452,384
3,956,400
79,548
Subtotal Subpart B CDER ...........................................................................
..........................
........................
100,261
........................
20,215,682
Subpart C—Administrative Actions: §§ 312.40 through 312.48
§ 312.42; clinical holds and requests for modifications ......................................
§ 312.44(c) and (d); sponsor responses to FDA when IND is terminated .........
§ 312.45(a) and (b); sponsor requests for or responses to an inactive status
determination of an IND by FDA .....................................................................
§ 312.47; meetings, including ‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’
meetings ..........................................................................................................
Subtotal Subpart C CDER ...........................................................................
181
1
1.28
1
232
1
284
16
65,888
16
213
1.72
367
12
4,404
174
2.885
502
160
80,320
..........................
........................
1,102
........................
150,628
khammond on DSKJM1Z7X2PROD with NOTICES
Subpart D—Responsibilities of Sponsors and Investigators
§ 312.54(a); sponsor submissions to FDA concerning investigations involving
an exception from informed consent under § 50.24 ........................................
§ 312.54(b); sponsor notifications to FDA and others concerning an institutional review board determination that it cannot approve research because
it does not meet the criteria in the exception from informed consent in
§ 50.24(a) .........................................................................................................
§ 312.56; review of ongoing investigations and associated notifications ...........
§ 312.58; inspection of records and reports by FDA ..........................................
§ 312.70; disqualification of a clinical investigator by FDA .................................
7
1.14
8
48
384
2
4,570
73
5
1
5.4689
1
1
2
24,993
73
5
48
80
8
40
96
1,999,440
584
200
Subtotal Subpart D CDER ...........................................................................
..........................
........................
25,081
........................
2,000,704
Subpart F—Miscellaneous: §§ 312.110 through 312.145
§ 312.110(b)(4) and (b)(5); written certifications and written statements submitted to FDA relating to the export of an investigational drug ......................
§ 312.120(b); submissions to FDA of ‘‘supporting information’’ related to the
use of foreign clinical studies not conducted under an IND ...........................
§ 312.120(c); waiver requests submitted to FDA related to the use of foreign
clinical studies not conducted under an IND ..................................................
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I
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8
22.375
179
75
13,425
1,964
7.352
14,440
32
462,080
68
1.5
102
24
2,448
Sfmt 4703
E:\FR\FM\24NON1.SGM
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67065
Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
Average
burden per
response
Total annual
responses
Total hours
§ 312.130; requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 ................
§ 312.145; Guidance Documents:
Oversight of Clinical Investigations (2013) .........................................................
Pharmacogenomic Data Submissions (2005) ....................................................
Adaptive Designs for Clinical Trials of Drugs and Biologics (2019) ...................
3
1
3
8
24
88
1
55
1.5
1
4.727
132
1
260
4
50
50
528
50
13,000
Subtotal Subpart F CDER ...........................................................................
..........................
........................
15,117
........................
491,555
Total ......................................................................................................
..........................
........................
142,114
........................
22,872,609
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; information collection activity
Average
burden per
recordkeeping
Total annual
records
Total hours
Subpart D—Responsibilities of Sponsors and Investigators
§ 312.52(a); transfer of obligations to a contract research organization
§ 312.57; records showing the receipt, shipment, or other disposition
of the investigational drug and any financial interests.
§ 312.62(a); records on disposition of drugs .........................................
§ 312.62(b); records on case histories of individuals ............................
466
13,000
3.107
1
1,448
13,000
300 ..............................
100 ..............................
434,400
1,300,000
13,000
2,192
1
6.587
13,000
14,439
40 ................................
40 ................................
520,000
577,560
Subtotal Subpart D CDER ..............................................................
..........................
........................
41,887
.....................................
2,831,960
Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
§ 312.160(a)(3); records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.160(c); shipper records of alternative disposition of unused
drugs.
Subtotal ...........................................................................................
547
1.43
782
0.50 (30 minutes) .......
391
547
1.43
782
0.50 (30 minutes) .......
391
..........................
........................
1,564
.....................................
782
Total .........................................................................................
..........................
........................
43,451
.....................................
2,832,742
I
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects
program changes and adjustments. We
have revised the information collection
to account for burden that may be
incurred by respondents who choose to
adopt or implement recommendations
discussed in referenced Agency
guidance documents intended to assist
respondents in complying with
regulatory requirements in part 312. We
have also made adjustments to
individual collection elements. As a
result of these changes and adjustments,
the information collection reflects an
overall decrease in both annual
responses and burden hours. Finally, we
have removed burden we attribute to
provisions in part 312, subpart I:
Expanded Access to Investigational
Drugs for Treatment Use and are
revising OMB control number 0910–
0814 to include burden associated with
information collection applicable to
these regulatory provisions for
efficiency of Agency operations.
VerDate Sep<11>2014
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Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25615 Filed 11–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2122]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TRODELVY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TRODELVY and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
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Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 24, 2022.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 23, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 24,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 24, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
E:\FR\FM\24NON1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67060-67065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25615]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1721]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Application Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with investigational new drug application requirements.
DATES: Submit either electronic or written comments on the collection
of information by January 24, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 24, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 24, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and
[[Page 67061]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1721 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Investigational New Drug
Applications.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Investigational New Drug Applications--21 CFR Part 312
OMB Control Number 0910-0014--Revision
This information collection supports implementation of provisions
of section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355) and of the licensing provisions of the Public Health
Service Act (42 U.S.C. 201 et seq.) that govern investigational new
drugs and investigational new drug applications (INDs). Implementing
regulations are found in part 312 (21 CFR part 312), and provide for
the issuance of guidance documents (see Sec. 312.145 (21 CFR 312.145))
to assist persons in complying with the applicable requirements. The
information collection applies to all clinical investigations subject
to section 505 of the FD&C Act and include the following types of INDs:
An Investigator IND is submitted by a physician who both
initiates and investigates, and under whose immediate direction the
investigational drug is administered or dispensed. A physician might
submit a research IND to propose studying an unapproved drug or an
approved product for a new indication or in a new patient population.
Emergency Use IND allows FDA to authorize use of an
experimental drug in an emergency situation that does not allow time
for submission of an IND in accordance with Sec. 312.23 or Sec.
312.20 (21 CFR 312.23 or 312.20). It is also used for patients who do
not meet the criteria of an existing study protocol or if an approved
study protocol does not exist.
Treatment IND is submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-threatening
conditions while the final clinical work is conducted and FDA's review
takes place.
There are two IND categories: Commercial and research (non-
commercial).
General IND requirements include submitting an initial application
as well as amendments to that application; submitting reports on
significant revisions of clinical investigation plans; submitting
information to the clinical trials data bank (https://clinicaltrials.gov) established by the National Institutes of Health/
National Library of Medicine, including expanded information on certain
clinical trials and information on the results of these clinical
trials; and reporting information on a drug's safety or effectiveness.
In addition, sponsors are required to provide to FDA an annual summary
of the previous year's clinical experience. The regulations also
include recordkeeping requirements regarding the disposition of drugs,
records regarding individual case histories, and certain other
documentation verifying clinical investigators' fulfillment of
responsibilities.
Form FDA 1571 entitled ``Investigational New Drug Application
(IND)'' and Form FDA 1572 entitled ``Statement of Investigator,'' were
developed to assist respondents with the information collection and
provide for uniform reporting of required data elements. The
information is required to be submitted electronically. Individuals who
are interested in receiving printed forms may send an email request to
the FDA Forms Manager at
[[Page 67062]]
[email protected] Fees may apply. Sponsors (including sponsor-
investigators) interested in filing or updating a research IND may use
a new web-based interface developed for use by mobile device or desktop
to help in completing Form FDA 1571. The web-based interface also
allows respondents to electronically submit completed Form FDA 1571 and
associated files. For more information regarding Forms FDA 1571 and
1572 visit https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572.
Human drug, biological product, and device product submissions must
be accompanied by Form FDA 3674, ``Certification To Accompany Drug,
Biological Product, and Device Applications or Submissions.'' The
guidance document ``Form FDA 3674--Certifications To Accompany Drug,
Biological Product, and Device Application'' (November 2017) is
available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions
and provides instruction on completing and submitting this information
to FDA. As communicated in the instructions, the certification must
accompany the application or submission and be included at the time of
submission to FDA.
Regulations in part 312, subpart B, specify content and format
requirements for applications, amendments, annual reporting, and
withdrawals, including content and format requirements for protocol and
information amendments. The regulations also explain phases of an
investigation and set forth principles of IND submissions.
Regulations in part 312, subpart C, describe administrative actions
pertaining to respondents' requests for and responses to clinical
holds, terminations, and inactive IND status determinations, as well as
various types of meetings (for example, End-of-Phase 2 and Pre-new drug
application (NDA) meetings).
Regulations in part 312, subpart D, set forth sponsor and
investigator responsibilities, including general responsibilities;
transfer of obligations to a contract research organization;
recordkeeping and record retention controls; reporting
responsibilities; and responsibility for disposition of unused supply
of investigational drug. The regulations also provide for investigator
controls including review of ongoing investigations; compliance with
requirements regarding the protection of human subjects and
institutional review board assurance; and disqualification of clinical
investigators.
Regulations in part 312, subpart E, sets forth requirements
applicable to drugs intended to treat life-threatening and severely
debilitating illnesses. The regulations establish procedures to reflect
that physicians and patients accept greater risk or side effects from
products that treat life-threatening and severely debilitating
illnesses than they would accept from products that treat less serious
illnesses. The procedures also reflect the recognition that the
benefits of the drug need to be evaluated in light of the severity of
the disease being treated.
Regulations in part 312, subpart F, include provisions pertaining
to import and export requirements; foreign clinical studies not
conducted under an IND; the disclosure of data and information in an
IND; and the issuance of guidance documents. We are revising the
information collection to account for burden that may be associated
with recommendations found in Agency guidance documents.
The guidance document entitled ``Oversight of Clinical
Investigations'' (August 2013) communicates risk-based monitoring
strategies and recommends plans for investigational studies of medical
products, including human drug and biological products, medical
devices, and combinations thereof. The guidance document is intended to
enhance human subject protection and the quality of clinical trial data
by focusing sponsor oversight on the most important aspects of study
conduct and reporting. The guidance also communicates that sponsors can
use a variety of approaches to fulfill responsibilities for monitoring
clinical investigator conduct and performance in IND studies, and
provides a description of strategies for monitoring activities to
reflect a modern, risk-based approach.
The guidance document entitled ``Pharmacogenomic Data
Submissions'' (March 2005) provides recommendations intended to assist
sponsors submitting or holding INDs, NDAs, or biologics license
applications (BLAs) with submission requirements for relevant data
regarding drug safety and effectiveness (including Sec. Sec. 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12 (21 CFR
312.22, 312.23, 312.31, 312.33, 314.50, 314.81, 601.2 and 601.12)).
Because the regulations were developed before the advent of widespread
animal or human genetic or gene expression testing, the regulations do
not specifically address when such data must be submitted. The guidance
document includes content and format recommendations regarding
pharmacogenomic data submissions. Although we have not received any
pharmacogenomic submissions since 2013, we assume an average of 50
hours for preparing and providing information to FDA as recommended in
the guidance and estimate one submission annually.
The guidance document entitled ``Adaptive Designs for
Clinical Trials of Drugs and Biologics'' (December 2019) was developed
to assist sponsors and applicants submitting INDs, NDAs, BLAs, or
supplemental applications on the appropriate use of adaptive designs
for clinical trials to provide evidence of the effectiveness and safety
of a drug or biologic. The guidance document describes important
principles for designing, conducting, and reporting the results from an
adaptive clinical trial, and advises sponsors on the types of
information to submit to facilitate FDA evaluation of clinical trials
with adaptive designs, including Bayesian adaptive and complex trials
that rely on computer simulations for their design.
The referenced guidance documents are available for download from
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-document and were issued consistent with Sec. 312.145 to help
respondents comply with requirements in part 312. In publishing the
respective notices of availability for each guidance document, we
included an analysis under the PRA and invited public comment on the
associated information collection recommendations. In addition, all
Agency guidance documents are issued in accordance with our Good
Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
Regulations in part 312, subpart G, provide for drugs for
investigational use in laboratory research animals or in vitro tests.
We estimate the burden of this collection of information as
follows:
[[Page 67063]]
Table 1--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; information Number of responses per Total annual Average burden Total hours
collection activity respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions: Sec. Sec. 312.1 through 312.10
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for 454 1.528 694 24 16,656
FDA advice on the applicability
of part 312 to a planned
clinical investigation.........
Sec. 312.8; requests to charge 14 1.64 23 48 1,104
for an investigational drug....
Sec. 312.10; waiver requests.. 5 1 5 24 120
-------------------------------------------------------------------------------
Subtotal Subpart A Center .............. .............. 722 .............. 17,880
for Biologics Evaluation
and Research (CBER)........
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND): Sec. Sec. 312.20 through 312.38 (Including Forms FDA
1571, 1572, and 3674)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); 2,075 3.382 7,018 300 2,105,400
IND content and format.........
Sec. 312.30(a) through (e); 1,781 4.6692 8,316 284 2,361,744
Protocol amendments............
Sec. 312.31(b); information 169 2.48 419 100 41,900
amendments.....................
Sec. 312.32(c) and (d); IND 224 10.59 2,372 32 75,904
Safety reports.................
Sec. 312.33(a) through (f); 971 2.2739 2,208 360 794,880
IND Annual reports.............
Sec. 312.38(b) and (c); 712 3.057 2,177 28 60,956
notifications of withdrawal of
an IND.........................
-------------------------------------------------------------------------------
Subtotal Subpart B CBER..... .............. .............. 22,510 .............. 5,440,784
----------------------------------------------------------------------------------------------------------------
Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds 154 1.65 254 284 72,136
and requests for modification..
Sec. 312.44(c) and (d); 86 1.22 105 16 1,680
sponsor responses to FDA when
IND is terminated..............
Sec. 312.45(a) and (b); 48 1.48 71 12 852
sponsor requests for or
responses to an inactive status
determination of an IND by FDA.
Sec. 312.47; meetings, 157 1.80 283 160 45,280
including ``End-of-Phase 2''
meetings and ``Pre-NDA''
meetings.......................
-------------------------------------------------------------------------------
Subtotal Subpart C CBER..... .............. .............. 713 .............. 119,948
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 through 312.70
----------------------------------------------------------------------------------------------------------------
Sec. 312.53(c); investigator 1,068 5.23 5,586 80 446,880
reports submitted to the
sponsor, including Form FDA-
1572, curriculum vitae,
clinical protocol, and
financial disclosure...........
Sec. 312.54(a); sponsor 4 4.25 17 48 816
submissions to FDA concerning
investigations involving an
exception from informed consent
under Sec. 50.24.............
Sec. 312.54(b); sponsor 1 1 1 48 48
notifications to FDA and others
concerning an institutional
review board determination that
it cannot approve research
because it does not meet the
criteria in the exception from
informed consent in Sec.
50.24(a).......................
Sec. 312.55(a); number of 473 2.224 1,052 48 50,496
investigator brochures
submitted by the sponsor to
each investigator..............
Sec. 312.55(b); number of 243 4.95 1,203 48 57,744
sponsor reports to
investigators on new
observations, especially
adverse reactions and safe use.
Sec. 312.56(b), (c), and (d); 915 2.948 2,698 80 215,840
review of ongoing
investigations and associated
notifications; sponsor
notifications..................
Sec. 312.58; inspection of 7 1 7 8 56
records and reports by FDA.....
Sec. 312.64; number of 2,728 3.816 10,411 24 249,864
investigator reports to the
sponsor, including progress
reports, safety reports, final
reports, and financial
disclosure reports.............
Sec. 312.70; disqualification 5 1 5 40 200
of a clinical investigator by
FDA............................
-------------------------------------------------------------------------------
Subtotal Subpart D CBER..... .............. .............. 20,980 .............. 1,021,944
----------------------------------------------------------------------------------------------------------------
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and (b)(5); 18 1 18 75 1,350
number of written
certifications and written
statements submitted to FDA
relating to the export of an
investigational drug...........
Sec. 312.120(b); number of 280 9.82 2,750 32 88,000
submissions to FDA of
``supporting information''
related to the use of foreign
clinical studies not conducted
under an IND...................
Sec. 312.120(c); number of 7 2.29 16 24 384
waiver requests submitted to
FDA related to the use of
foreign clinical studies not
conducted under an IND.........
Sec. 312.130; number of 350 1.342 470 8 3,760
requests for disclosable
information in an IND and for
investigations involving an
exception from informed consent
under Sec. 50.24.............
-------------------------------------------------------------------------------
Subtotal Subpart F CBER..... .............. .............. 3,254 .............. 93,494
-------------------------------------------------------------------------------
Total................... .............. .............. 48,179 .............. 6,694,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden for Biologics \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; information collection Number of records per Total annual Average burden per recordkeeping Total hours
activity recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 Through 312.70
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); sponsor records for the 94 2.26 212 2....................................... 424
transfer of obligations to a contract
research organization.
[[Page 67064]]
Sec. 312.57; sponsor recordkeeping showing 335 2.70 904 100..................................... 90,400
the receipt, shipment, or other disposition
of the investigational drug, and any
financial interest.
Sec. 312.62(a); investigator recordkeeping 453 1 453 40...................................... 18,120
of the disposition of drugs.
Sec. 312.62(b); investigator recordkeeping 453 1 453 40...................................... 18,120
of case histories of individuals.
----------------------------------------------------------------------------------------------------------
Subtotal Subpart D CBER.................. ............... .............. 2,022 ........................................ 127,064
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records pertaining to 111 1.40 155 0.5 (30 minutes)........................ 78
the shipment of drugs for investigational
use in laboratory research animals or in
vitro tests.
Sec. 312.160(c) shipper records of 111 1.40 155 0.5 (30 minutes)........................ 78
alternative disposition of unused drugs.
----------------------------------------------------------------------------------------------------------
Subtotal Subpart G CBER.................. ............... .............. 310 ........................................ 156
----------------------------------------------------------------------------------------------------------
Total................................ ............... .............. 2,332 ........................................ 127,220
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; information Number of responses per Total annual Average burden Total hours
collection activity respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for 419 1 419 24 10,056
FDA advice on the
applicability of part 312 to a
planned clinical investigation
Sec. 312.8; requests to 25 1.28 32 48 1,536
charge for an investigational
drug..........................
Sec. 312.10; requests to 68 1.5 102 24 2,448
waive a requirement in part
312...........................
--------------------------------------------------------------------------------
Subtotal Subpart A Center ............... .............. 553 .............. 14,040
for Drug Evaluation and
Research (CDER)...........
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); 4,886 1.4662 7,164 300 2,149,200
IND content and format
(including Forms FDA 1571 and
3674).........................
Sec. 312.30(a) through (e); 11,847 3.2367 38,346 284.25 10,899,850
protocol amendments...........
Sec. 312.31(b); Information 8,094 3.30899 26,783 100 2,678,300
amendments....................
Sec. 312.32(c) and (d); IND 892 15.848 14,137 32 452,384
safety reports................
Sec. 312.33(a) through (f); 3,777 2.9097 10,990 360 3,956,400
IND annual reports............
Sec. 312.38(b) and (c); 1,549 1.834 2,841 28 79,548
notifications of withdrawal of
an IND........................
--------------------------------------------------------------------------------
Subtotal Subpart B CDER.... ............... .............. 100,261 .............. 20,215,682
----------------------------------------------------------------------------------------------------------------
Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds 181 1.28 232 284 65,888
and requests for modifications
Sec. 312.44(c) and (d); 1 1 1 16 16
sponsor responses to FDA when
IND is terminated.............
Sec. 312.45(a) and (b); 213 1.72 367 12 4,404
sponsor requests for or
responses to an inactive
status determination of an IND
by FDA........................
Sec. 312.47; meetings, 174 2.885 502 160 80,320
including ``End-of-Phase 2''
meetings and ``Pre-NDA''
meetings......................
--------------------------------------------------------------------------------
Subtotal Subpart C CDER.... ............... .............. 1,102 .............. 150,628
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
----------------------------------------------------------------------------------------------------------------
Sec. 312.54(a); sponsor 7 1.14 8 48 384
submissions to FDA concerning
investigations involving an
exception from informed
consent under Sec. 50.24....
Sec. 312.54(b); sponsor 2 1 2 48 96
notifications to FDA and
others concerning an
institutional review board
determination that it cannot
approve research because it
does not meet the criteria in
the exception from informed
consent in Sec. 50.24(a)....
Sec. 312.56; review of 4,570 5.4689 24,993 80 1,999,440
ongoing investigations and
associated notifications......
Sec. 312.58; inspection of 73 1 73 8 584
records and reports by FDA....
Sec. 312.70; disqualification 5 1 5 40 200
of a clinical investigator by
FDA...........................
--------------------------------------------------------------------------------
Subtotal Subpart D CDER.... ............... .............. 25,081 .............. 2,000,704
----------------------------------------------------------------------------------------------------------------
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and 8 22.375 179 75 13,425
(b)(5); written certifications
and written statements
submitted to FDA relating to
the export of an
investigational drug..........
Sec. 312.120(b); submissions 1,964 7.352 14,440 32 462,080
to FDA of ``supporting
information'' related to the
use of foreign clinical
studies not conducted under an
IND...........................
Sec. 312.120(c); waiver 68 1.5 102 24 2,448
requests submitted to FDA
related to the use of foreign
clinical studies not conducted
under an IND..................
[[Page 67065]]
Sec. 312.130; requests for 3 1 3 8 24
disclosable information in an
IND and for investigations
involving an exception from
informed consent under Sec.
50.24.........................
Sec. 312.145; Guidance
Documents:
Oversight of Clinical 88 1.5 132 4 528
Investigations (2013).........
Pharmacogenomic Data 1 1 1 50 50
Submissions (2005)............
Adaptive Designs for Clinical 55 4.727 260 50 13,000
Trials of Drugs and Biologics
(2019)........................
--------------------------------------------------------------------------------
Subtotal Subpart F CDER.... ............... .............. 15,117 .............. 491,555
--------------------------------------------------------------------------------
Total.................. ............... .............. 142,114 .............. 22,872,609
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden for Human Drugs \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; information collection Number of records per Total annual Average burden per recordkeeping Total hours
activity recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); transfer of obligations to 466 3.107 1,448 300..................................... 434,400
a contract research organization.
Sec. 312.57; records showing the receipt, 13,000 1 13,000 100..................................... 1,300,000
shipment, or other disposition of the
investigational drug and any financial
interests.
Sec. 312.62(a); records on disposition of 13,000 1 13,000 40...................................... 520,000
drugs.
Sec. 312.62(b); records on case histories 2,192 6.587 14,439 40...................................... 577,560
of individuals.
----------------------------------------------------------------------------------------------------------
Subtotal Subpart D CDER.................. ............... .............. 41,887 ........................................ 2,831,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records pertaining to 547 1.43 782 0.50 (30 minutes)....................... 391
the shipment of drugs for investigational
use in laboratory research animals or in
vitro tests.
Sec. 312.160(c); shipper records of 547 1.43 782 0.50 (30 minutes)....................... 391
alternative disposition of unused drugs.
Subtotal................................. ............... .............. 1,564 ........................................ 782
----------------------------------------------------------------------------------------------------------
Total................................ ............... .............. 43,451 ........................................ 2,832,742
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The information collection reflects program changes and
adjustments. We have revised the information collection to account for
burden that may be incurred by respondents who choose to adopt or
implement recommendations discussed in referenced Agency guidance
documents intended to assist respondents in complying with regulatory
requirements in part 312. We have also made adjustments to individual
collection elements. As a result of these changes and adjustments, the
information collection reflects an overall decrease in both annual
responses and burden hours. Finally, we have removed burden we
attribute to provisions in part 312, subpart I: Expanded Access to
Investigational Drugs for Treatment Use and are revising OMB control
number 0910-0814 to include burden associated with information
collection applicable to these regulatory provisions for efficiency of
Agency operations.
Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25615 Filed 11-23-21; 8:45 am]
BILLING CODE 4164-01-P
